We are looking for a Quality/Testing Engineer I. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements to optimize product development, internal and external device manufacturing, and device distribution.
QUALIFICATIONS:
Perform testing, assess results, and document routine complaint product device evaluations in support of complaint investigations including dimensional and functional analysis.
Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including technical review of device history records (DHR review), in support of complaint investigations
Collaborate with other engineers on non-routine testing in support of failure investigation and root cause analysis.
Plan, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines.
Generate weekly complaint reports to provide data for weekly production meetings.
Organize and track complaint product returns and investigational follow-up inquiries related to product investigations in partnership with complaint handlers.
Perform queries on historical complaint data to support complaint investigations.
Collaborate with other Engineers in preliminary complaint product evaluations to determine standard or non-routine device failures. Document, communicate, and escalate results, as applicable.
SKILLS
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
EDUCATION and EXPERIENCE
Bachelor’s degree in scientific or engineering field, and previous quality compliance and medical device (cardiovascular, endovascular, or other surgical products), healthcare, or a related en